Analysis of a Biomarker Signature in Patients With Multiple Sclerosis (MS) Treated With Gilenya (FTY720)

Multiple Sclerosis Clinical Trial

— MS  

Official title:

Analysis of a Biomarker Signature, Consisting of Toll-like Receptor 2 (TLR2), TLR4 and CCR1, by Flow Cytometry in Patients With MS Treated With Gilenya (FTY720)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02408380
• Other study ID #: CFTY720DCA05T
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2015
• Last updated: April 2, 2015
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: McGill University
• Contact: Leslie Fitz-Gerald, MSc.
• Phone: 514-398-7192
• Email: leslie.fitz-gerald[@]mail.mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

This study investigates whether there is a link between disease activity/progression in patients receiving Gilenya and expression of a putative biomarker signature in patients with multiple sclerosis.

Description:

Gilenya modulates expression of the sphingosine-1-phosphate receptor and inhibits egress of several lymphocyte subsets from lymph nodes. This results in immunosuppression that has a beneficial effect in patients with multiple sclerosis.

Our laboratory reported that increased expression of a possible biomarker signature, consisting of TLR2, TLR4 and CCR1, in a T-subset is associated with rapid MS progression. The investigators will test whether a significant proportion of patients at baseline upregulate this biomarker signature in one or more T-subsets, whether expression of this biomarker signature changes with treatment with Gilenya and whether expression levels of this signature predict disease activity or progression over a 12 month followup period. The investigators will study patients who are already being treated with Gilenya by their neurologists or who are already being treated with Gilenya as part of a clinical trial sponsored by Novartis Pharmaceuticals Canada. Patients will not be treated with Gilenya for the purposes of our study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Treatment with Gilenya

Exclusion Criteria:

• Subject is under 18 or over 65.

• Subject has less than 4 weeks of discontinuation with steroid treatment for a relapse.

• Subject cannot communicate reliably with investigator.

• Vulnerable subjects exclude, namely patients defined as those without freedom by the law (e.g. prisoners or by administrative decision) or people hospitalized without their consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in expression of a biomarker signature		12 months	No